Inflexal V
Influenza vaccine (surface antigen, inactivated, virosomic). Injectable suspension, season 2005/2006

Composition:
Inflexal V is an inactivated anti-Influenza vaccine which has virosomes in its formulation acting as carrier/adjuvant and it is composed by highly purified surface antigens of Influenza virus strains A and B, propagated in chicken eggs fertilized and inactivated with ß propiolactone.

The composition of anti-Influenza vaccines is updated every years based on the recommendations of
The World Health Organization for the North hemisphere and according to the decisions of the European Union
(CPMP).

Following the recommendations and the decisions for the season of 2005/2006, each dose of 0.5 ml vaccine contains surface antigens* prepared from the following strains:

A/California/7/2004 (H3N2) (A/New York/55/2004 NYMC X-157) 15 micrograms** A/New Caledonia/20/99 (H1N1) (A/New Caledonia/20/99 IVR-116) 15 micrograms** B/Shanghai/361/2002 (B/Jiangsu/10/2003) 15 micrograms**

* propagated in chicken eggs
** hemaglutinine

Pharmaceutical form and content
Neutral, transparent glass vial (type I), prefilled, sterile and ready to use containing 0.5 ml of injectable suspension.

Packages with 1 or 10 disposable syringes.

Pharmacotherapeutic class:
18.1 vaccines (simple or conjugated)

M.A. Holder:
Istituto Sieroterapico Berna S.r.l. Via Bellinzona 39
I-22100 COMO Italy

Represented in Portugal:
ANGELINI FARMACÊUTICA, LDA Rua João Chagas, nº 53 – 3º Piso
1495-072 Algés

Therapeutic indications:
Inflexal V is indicated in the prophylaxis of influenza, particularly in people who are at increased risk due to associated complications.

Contraindications:
Hypersensitivity to the active substances, to any of the excipients, eggs, chicken proteins, polymixine B or neomycin.
Vaccination should be postponed in people with fever or acute infections.

Undesirable effects:
Adverse reactions observed in clinical assays, listed according to their incidence: Common (>1/100, <1/10):
Local reactions: redness, swelling, pain, ecchymosis, induration.
Systemic reactions: Fever, malaise, tremors, fatigue, headache, sudoresis, muscle pains and joint pains.
These reactions generally disappear without treatment within 1-2 days. Additionally, post-marketing surveillance has reported the following adverse effects:
Uncommon (>1/1.000, <1/100):
General cutaneous reactions such as pruritus, urticaria and non specific cutaneous eruption (rash).

Rare (>1/10.000, <1/1.000):
Nevralgia, paresthesias, convulsions, transient trombocytopenia.
Allergic reactions have been registered which in rare cases have lead to shock.

Very rare (<1/10.000):
Vasculitis with transient renal disorders.
Neurological disorders such as encephalomyelitis, nevritis and Guillain-Barré syndrome.

Drug interactions and other forms of interactions:
Inflexal V may be administered simultaneously with other vaccines. However, the vaccines have to be administered on different limbs. One should bear in mind that the simultaneous administration may enhance the adverse reactions.
The immunological response may be reduced in individuals undergoing an immunosuppressor treatment.
Following vaccination against Influenza, false positive results may be obtained in serological tests performed with the ELISA method for the identification of antibodies against HIV-1, C hepatitis and, particularly, HTLV-1. In these cases the Western Blot method is negative. These transient false positive results may be caused by IgM produced as a response to the vaccine.

Warnings and special precautions for use:
Like with other injectable vaccines, there should be always adequate treatment and medical supervision available for the rare cases of the occurrence of an anaphylactic reaction after the application of the vaccine.

Inflexal V should not, at any circumstance, be administered by intravenous route.

The vaccine may contain trace amounts of polymixine B and neomycin below the analytical detection limit. Use with caution in individuals with history of hypersensitivity to these antibiotics.

Antibodies' response may be insufficient in patients with immune deficiency, either endogenous (due to a disease), or iatrogenic (due to medicines).

Pregnancy and lactation:
Although limited, the available date on the vaccination of pregnant women does not indicate the occurrence of foetal and maternal adverse effects, susceptible of being attributed to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy onwards.

In pregnant women presenting clinical problems that may be worsened due to Influenza, it is recommended the administration of the vaccine regardless of the gestation stage.

Inflexal V may be used during lactation.

Effects on the ability to drive and use machines:
It is not probable that Inflexal V may affect the ability to drive and use machines.

Excipients:
Inflexal V contains the following excipients: Sodium chloride, disodium dehydrogenate phosphate, potassium dehydrogenate phosphate , lecithin and water for injectable preparations.

Posology and administration mode:
Adults and children above 36 months: 0.5 ml

Children between 6 and 35 months: the clinical data available is limited. The doses that have been used are doses of 0.25 ml or 0.5 ml.

In children, who have not been previously vaccinated, a second dose should be administered with an interval of at least 4 weeks.

The immunization must be performed through an intramuscular injection or a deeps subcutaneous injection.

Instructions for use:
Allow the vaccine to reach room temperature before its administration. Agitate before using.
When administering a dose of 0.25 ml, the prefilled syringe must be hold in the upright position and half the volume should be discarded. The remaining volume is injected.

Overdosage:
It is not probable that overdosage may cause undesirable effects.
Any undesirable effect not included in this patient leaflet should be reported to your doctor or pharmacist.

Do not use after the expiry term stated on the labelling and package.

Special precautions for storage:
Inflexal V should be stored at a temperature between +2 ºC and +8 ºC (in a refrigerator). Do not freeze.
The vaccine cannot be used if it was inadvertently frozen. Keep the syringe inside the original outer package, protected from light.

Other information:
Seroprotection is generally achieved within 2 to 3 weeks. After the vaccination, the duration of the immunity to homologous strains or strains closely related to the vaccine strains may vary, but is normally between 6 to 12 months.

August 2005

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